Randomised double blind clinical trial in acute severe colitis: The IASO Trial

Phase 2

Completed

• Conditions: Acute Severe Colitis; Digestive System

• Registration Number: ISRCTN43717130
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30772849 protocol (added 04/03/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-12
• Study Completion: 2023-05-31
• Last Update Posted: 5 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

1. Be aged 16–80 years inclusive
2. Have given written informed consent to participate
3. Be hospitalised with clinically confirmed or suspected diagnosis of acute severe ulcerative colitis and a MTWSI score =11
4. Have a requirement for treatment with IV corticosteroids in the judgement of the treating clinician, with the possibility to receive a first dose of trial drug within 36 hours of commencement of IV corticosteroids

Exclusion Criteria

Current exclusion criteria as of 21/02/2018:
1. Pregnant or breast-feeding women
2. Oral corticosteroid dosing for a duration of 8 weeks or more immediately prior to commencement of IV corticosteroid dosing
3. History of severe hepatic impairment (e.g. Child-Pugh = Grade C)
4. Moderate or Severe renal impairment (estimated glomerular filtration rate [eGFR] <60ml/min/1.73m2)
5. Neutropenia (neutrophil count < 1.5x109/l)
6. Previous treatment with anakinra for any indication
7. Evidence (from blood cultures etc) or clinical suspicion of systemic infection
8. Current or previous cytomegalovirus (CMV) infection requiring treatment with anti-viral agents
9. Current treatment with anti-TNF-a therapy or anti-TNF-a discontinuation within previous 16 weeks
10. A history of pulmonary TB infection
11. History of malignancy (with the exception of non-melanoma skin cancer) or colonic dysplasia
12. Receipt of another IMP as part of a CTIMP within the previous 16 weeks

Previous exclusion criteria:
1. Pregnant or breast-feeding women
2. Oral corticosteroid dosing for a duration of 8 weeks or more immediately prior to commencement of IV corticosteroid dosing
3. History of severe hepatic impairment (e.g. Child-Pugh = Grade C)
4. Moderate or severe renal impairment (eGFR < 50ml/minute)
5. Neutropenia (neutrophil count < 1.5x109/l)
6. Previous treatment with anakinra for any indication
7. Evidence (from blood cultures etc) or clinical suspicion of systemic infection
8. Current or previous cytomegalovirus (CMV) infection requiring treatment with anti-viral agents
9. Current treatment with anti-TNF-a therapy or anti-TNF-a discontinuation within previous 16 weeks
10. A history of pulmonary TB infection
11. History of malignancy (with the exception of non-melanoma skin cancer) or colonic dysplasia
12. Receipt of another IMP as part of a CTIMP within the previous 16 weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified